Back To Schedule
Tuesday, June 25 • 10:30am - 11:30am
#236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-608-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore and discuss agency-wide patient engagement programs and initiatives that provide patient stakeholders (patients, caregivers and advocates) opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review.

Learning Objectives

Describe how FDA has established organizational components to ensure patients are a priority; Describe avenues for patient stakeholders to engage with the agency; Explain key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss the value of patient stakeholder participation.


Samir Shaikh, MBA


FDA Perspective
Patroula Smpokou, MD

Patient Perspective
Debbie Drell

Patient Perspective
Sabina A. Kineen

avatar for Debbie Drell

Debbie Drell

Director of Membership, National Organization for Rare Disorders (NORD)
Debbie joined the National Organization for Rare Disorders (NORD) in 2017 with more than 18 years of nonprofit experience in public health education, awareness and advocacy. Most recently, she worked for the Pulmonary Hypertension Association, a NORD member organization. Debbie says... Read More →
avatar for Sabina Kineen

Sabina Kineen

Fabry Disease, Patient Advocate
Diagnosed with Fabry Disease in her early teens, Sabina provides a unique perspective as both a patient and caregiver. Over the years, she has shared her experiences living with a rare genetic condition, as well as helping manage the complicated and multi-faceted healthcare needs... Read More →
avatar for Patroula Smpokou

Patroula Smpokou

Deputy Director, Office of New Drugs, CDER, FDA
Patroula Smpokou, MD, currently serves as an acting deputy director in the Division of Rare Diseases and Medical Genetics at FDA’s Center for Drug Evaluation and Research where she is involved in the scientific review and regulation of products intended for rare genetic diseases... Read More →
avatar for Samir Shaikh

Samir Shaikh

Deputy Director, Patient Affairs Staff, Office of the Commissioner, FDA
Samir Shaikh works at the U.S. Food and Drug Administration (FDA) and serves as the Deputy Director for the Patient Affairs Staff (PAS) in the Office of the Commissioner. PAS leads and enhances patient engagement activities across the medical product Centers—facilitating dialogue... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session